Designed & created by

Gavin Wright

Terms & Conditions    30 Smilie, Peterlee, Co.Durham, England. SR8 4AN    e-mail

There was a queery placed on the National Back Exchange web site asking the question of whether Slide sheets are medical equipment or not. To me the obvious answer was if the Medicines and Healthcare products Regulatory Agency had ever placed a warning on these products that would have provided the answer…But they haven’t…So I asked them. There answer is outlined in full below.

MHRA is a site well worth visiting and registering for product warnings etc.

A product can be defined as a Medical Device if it complies with the definition of a Medical Device under the Medical Devices Directive (MDD) 93/42/EEC Article 1 Clause 2a. Therefore in order to be classified a medical device, a product must be intended to provide or assist with the diagnosis, monitoring, prevention or treatment of a medical condition. This will not only depend on the device itself, but also on the claims made by the manufacturer for its intended use in the accompanying documentation (Article 3 annex I).

As long as the slide sheets are clearly intended for use to assist movement of patients with medical conditions that prevent them from moving themselves, then we consider the sheets to be Medical Devices. These are likely to fall in Class I, so no Notified Body assessments are required.

Under the MDD 93/42/EEC, in order to affix the CE mark, the manufacturer or authorised representative must follow the relevant conformity assessment procedure leading to CE marking of the product. Any manufacturer based outside the EU must designate an Authorised Representative (AR). The appointed AR must provide written evidence that they are acting with the consent of a manufacturer located outside the European Community. This may take the form of a letter of designation/contract from the overseas manufacturer.

The letter should state the full name and address of the AR and that they are the designated EU Authorised Representatives based within the UK, under MDD 93/42/EEC.

Class I devices are CE-marked based on self-declaration in accordance with the MDD Annex VII. In accordance with Article 14 of the Medical Devices Directive 93/42/EEC, manufacturers and/or authorised representatives based in the UK of class I medical devices require registration with a Competent Authority; within the UK this would be the MHRA. In order to complete the process please read guidance note 7 and 8, guidance notes for manufacturers of class I medical devices and guidance notes for the registration of persons placing devices on the market and complete the RG2 form. The form attached with the registration fee of £70.00 should be sent to us, all the documents mentioned above can be found on the webpage links supplies below:

Guidance note 7: guidance for manufacturers of Class I Medical Devices

http://www.mhra.gov.uk/home/ groups/es-era/documents/publication/con0 07511.pdf

Guidance note 8: guidance note for the registration of persons placing devices on the market (please scroll down)

http://www.mhra.gov.uk/Howw eregulate/Devices/Registrationof medicaldevices/index.htm

Appendix A and B

http://www.mhra.gov.uk/home/ groups/es-era/documents/publication/con0 07513.pdf

Registration form RG2:

http://www.mhra.gov.uk/home/ groups/es-era/documents/publication/con0 07514.pdf

As long as the slide sheets are clearly intended for use to assist movement of patients with medical conditions that prevent them from moving themselves, then we consider the sheets to be Medical Devices. These are likely to fall in Class I, so no Notified Body assessments are required.

Under the MDD 93/42/EEC, in order to affix the CE mark, the manufacturer or authorised representative must follow the relevant conformity assessment procedure leading to CE marking of the product. Any manufacturer based outside the EU must designate an Authorised Representative (AR). The appointed AR must provide written evidence that they are acting with the consent of a manufacturer located outside the European Community. This may take the form of a letter of designation/contract from the overseas manufacturer.

The letter should state the full name and address of the AR and that they are the designated EU Authorised Representatives based within the UK, under MDD 93/42/EEC.

Class I devices are CE-marked based on self-declaration in accordance with the MDD Annex VII. In accordance with Article 14 of the Medical Devices Directive 93/42/EEC, manufacturers and/or authorised representatives based in the UK of class I medical devices require registration with a Competent Authority; within the UK this would be the MHRA. In order to complete the process please read guidance note 7 and 8, guidance notes for manufacturers of class I medical devices and guidance notes for the registration of persons placing devices on the market and complete the RG2 form. The form attached with the registration fee of £70.00 should be sent to us, all the documents mentioned above can be found on the webpage links supplies below:

Guidance note 7: guidance for manufacturers of Class I Medical Devices

http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007511.pdf

Guidance note 8: guidance note for the registration of persons placing devices on the market (please scroll down)

http://www.mhra.gov.uk/Howweregulate/Devices/Registrationofmedicaldevices /index.htm

Appendix A and B

http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007513.pdf

Registration form RG2:

http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007514.pdf